Service Description

To enroll new patients in a dosing extension trial as our product has a limited number of months to be used in label. The focus was to determine what if any is the effectiveness or safety change when not bound to a timeline for use.

What Went Well

Our main issue was to find how we would determine when therapy should be stopped and the type of analysis for the variability in therapy use. So we first started with there suggestion of a feasibility study to determine protocol issues. Our learning hopefully will benefit in the revised protocol design.

What Could Be Improved

To provide a better determination of time for recruitment. Other Cross have been able to provide a likely estimate. At this juncture we still have not gotten a good range for recruitment timing based on the studies complex design. In the end this could have been the same if dealing with another CRO because of the unique study design.

Lessons Learned from the Experience

Starting out to identity the challenge, but how to adapt to the challenges. They helped us avoid an amendment by going through the feasibility study. This alone save us thousands of dollars. But more important will help with a better trial design.